Kornimate/medical-research-clean huggingface dataset:
acth in progressive forms of ms

Conditions: Secondary Progressive Multiple Sclerosis; Primary Progressive Multiple Sclerosis; Progressive Relapsing Multiple Sclerosis

Summary: this is a phase ii, randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, and efficacy of adrenocorticotropic hormone (acth, acthar gel) administered as a pulsed regimen consisting of injections on three consecutive days per month in patients with progressive forms of multiple sclerosis (ms). patients will be randomly assigned to either an acth arm or a placebo arm. the main hypotheses are that 1) pulsed acth will be safe and well-tolerated, and 2) pulsed acth will slow progression of clinical and paraclinical measures of ms progression compared to placebo.


Eligibility criteria:
inclusion criteria: * male or female patients with a confirmed diagnosis of ms by mcdonald criteria * age \>/= 18 years * spms, ppms, or prms phenotype, according to lublin and reingold criteria * edss 2.0 - 6.0, inclusive * able to understand the consent process exclusion criteria: * known intolerance of acth or corticosteroids * diabetes mellitus, defined as pre-existing diagnosis, fasting blood glucose \> 125 mg/dl, or glycosylated hemoglobin \>/= 6.5% * osteoporosis, defined as pre-existing diagnosis or t-score on dual-energy x-ray absorptiometry (dexa) scan of \</= -2.5. * current serious medical condition which may interfere with subject's ability to complete the study, or for which pulsed acth therapy is contraindicated or might complicate current therapy (e.g., cancer, severe psychiatric illness, chronic infections, autoimmune disorders) * treatment with cytotoxic agents (including but not necessarily limited to mitoxantrone, cyclophosphamide, alemtuzumab, or rituximab) within 3 years prior to randomization * treatment with non-cytotoxic immunosuppressive agents (including but not necessarily limited to corticosteroids, acth, azathioprine, mycophenolate mofetil, methotrexate or natalizumab) within 3 months prior to randomization * treatment with fda-approved first-line ms disease-modifying therapies (b-interferon, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) will be permitted, as long as treatment has been ongoing and stable for at least 3 months prior to randomization * treatment with dalfampridine or compounded 4-aminopyridine (4-ap) will be permitted as long as treatment has been ongoing and stable for at least 3 months prior to randomization * stimulant medications for fatigue (such as methylphenidate, modafinil, armodafinil, amantadine or dextroamphetamine) will be permitted, but subjects will be asked to not take these medications on study visit days until all study procedures/assessments are completed.
treosulfan-based conditioning for transplantation in aml/mds

Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndrome

Summary: the study hypotheses is that the introduction of dose escalated treosulfan, in substitution to busulfan, will reduce toxicity after allogeneic transplantation while improving myeloablation and and disease control in patients with aml and mds not eligible for standard transplantation.


Eligibility criteria:
inclusion criteria: 1. age less than physiologic 68 years. 2. patients with aml and mds not eligible for standard tbi- or busulfan-based myeloablative conditioning due to age, concurrent medical condition, or extensive prior therapy (e.g. age \> 55 years for hla-matched sibling transplants or \> 50 for matched unrelated donor transplants, prior / concomitant pulmonary, liver, or other organ complications). 3. this study will only include patients with chemo-refractory disease or previously untreated active disease. a. acute myeloid leukemias (aml) according to who classification (\> 20% myeloblasts in peripheral blood or bone marrow at diagnosis) in induction failure, pr, untreated or chemo-refractory relapse. patients must have \> 10% marrow blasts at the time of transplantation. b. myelodysplastic syndromes (mds) according to who classification (\< 20% myeloblasts in peripheral blood and bone marrow at diagnosis), indicated for allogeneic transplantation: - refractory anaemia with excess blasts (raeb-1 and raeb-2) with no prior therapy 4. patients must have an hla matched related or unrelated donor willing to donate either peripheral blood stem cells or bone marrow. matching is based on high-resolution class i (hla-a, -b, -c) and class ii (hla-drb1, -dqb1) typing. the goal is to transplant \> 3 x 106 cd34+ cells per kg body weight of the recipient - exclusion criteria: 1. bilirubin \> 3.0 mg/dl, transaminases \> 3 times upper normal limit 2. creatinine \> 2.0 mg/dl 3. ecog-performance status \> 2 4. uncontrolled infection 5. pregnancy or lactation 6. abnormal lung diffusion capacity (dlco \< 40% predicted) 7. severe cardiovascular disease 8. cns disease involvement 9. pleural effusion or ascites \> 1 liter 10. known hypersensitivity to fludarabine or treosulfan 11. psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate -

Keywords: acute myeloid leukemia myelodysplastic syndrome allogeneic stem cell transplantation reduced-intensity conditioning treosulfan
modified exercise programme in individuals with parkinson's disease

Conditions: Parkinson Disease

Summary: a feasibility study using measures of turning function derived from inertial measurement unit sensory before, and after, a modified exercise programme approach.

participants will be patients diagnosed as having idiopathic pd by a neurologist. patients will be recruited from the movement disorder clinic, division of neurology, faculty of medicine siriraj hospital, mahidol university, thailand. participants will be classified into two groups; the treatment and the control groups. all participants will be asked to sign an informed consent form approved by the ethical committee of mahidol university institutional review board, mahidol university, thailand. only patients with pd who meet the inclusion and exclusion criteria will be invited to participate in the study. all participants will be assessed for daily activity and motor skill using the unified parkinson's disease rating scale (updrs). at pre- and post- assessments, eye movement and turning characteristics will be assessed using inertial measurement unit sensors and electroocculography (eog). the treatment group will receive a rehabilitation program by the physiotherapist. the rehabilitation sessions will take place at the faculty of physical therapy, mahidol university, thailand. the control group will receive a diary for recording their daily activities during the duration of participation in this study. in addition, the researcher will phone participants once per week to remind then to maintain their diary records. data processing \& analysis: this study will be used the outcome measures and processing data in matlab. statistical analysis: kolmogorov smirnov goodness of fit test will be used to test the data distribution. if the data are normal or non-normal distribution, data comparisons will be tested as the following; * normal distribution: mixed model anova will be used to compare outcome measures between pre- and post- and between the treatment and the control groups * non-normal distribution: the mann-whitney u test will be used to compare outcome measures between the treatment and control groups. wilcoxon signed-rank test will be used to compare outcome measures between pre- and post- assessments within group.

Eligibility criteria:
inclusion criteria: * presenting clinical diagnosis of parkinson's disease stage 2 to 3 by modified hoehn and yahr scale assessment * age ranges from 50-75 years * having stable pd medication usage at least 1 month * no wearing-off phenomenon * able to walk independently without using any assistive device * able to follow commands and instruction exclusion criteria: * presenting clinical diagnosis of dementia * having other neurological, cardiopulmonary, or lower extremities musculoskeletal problems which influence the test performance. * having high blood pressure \[more than 140/90 mmhg\] * having hemodialysis * having visual problems which cannot be adjusted by the lens or glasses

Keywords: parkinson's disease exercise rigidity turning
medical office intervention for adolescent drug use - attention study supplement

Conditions: Substance-related Disorders

Summary: this study will use the ccpt ii to assess attention in 12-21 year olds enrolled in a randomized controlled trial of a brief behavioral treatment for substance abuse. this study will describe at baseline levels of attention using a well validated instrument (connors continuous performance test ii) and explore the association between attention levels and substance use. the primary study hypothesis is that lower initial levels of substance use (as measured by percent days abstinent) will be associated with higher attention levels. we envision that this data will inform a better understanding of how attention may modify treatment response.

research among adolescents with substance use problems presents unique challenges to investigators. issues with recruitment, confidentiality, and follow-up have been cited as common limitations to research in this area. one likely contributor to decreased treatment persistence and follow-up is the limited ability to sustain attention that many adolescents, especially those with substance problems, may manifest. (taper, 2002) thus, assessing attention before beginning substance abuse treatment has the potential not only to inform the science of adolescent addiction medicine, but also to guide the development of therapies to specifically address attention deficits among adolescent substance users. adolescent outpatients being treated for substance problems have not been systematically studied for clinical or subclinical attention levels. the primary aims this study are as follows: 1. to test the feasibility of administering the connors continuous performance test ii (ccpt ii), a well validated measure of attention, to a sample of 12-21 year old patients receiving treatment for substance abuse. 2. to obtain baseline descriptive statistics on the ccpt ii in a previously understudied group of young patients receiving treatment for substance abuse. 3. to estimate the magnitude of the association between substance use and levels of attention at baseline before treatment. 4. to explore the degree to which attention may affect response to substance abuse treatment in general and specifically motivational interviewing.

Eligibility criteria:
inclusion criteria: * crafft score of 1 or more * have used cannabis, alcohol or another drug on at least two occasions during the 30 days preceding their visit * can read and understand english exclusion criteria: * require immediate hospitalization or referral to residential substance abuse treatment * will not be available to complete the study assessments over the next 9 months.

Keywords: alcohol abuse drug abuse
beta blocker therapy in mild to moderate asthmatics

Conditions: Asthma

Summary: current asthma medicines include inhalers. a common type of inhaler is called a 'beta-agonist' (e.g. salbutamol). they improve asthma symptoms by stimulating areas in the airway causing it to widen. although these drugs are useful short term, long term use can make asthma worse in some people. 'beta-blockers' are the complete opposite type of medication. just now they are avoided in patients with asthma. beta-blockers cause problems in asthmatics in the short term, including severe asthma attacks. the other mainstay of inhaler treatment for asthma is inhaled steroid or 'preventer' medication. these work by dampening down the inflammation in the lungs that occurs in asthma. new research has suggested that longer term use of beta-blockers can also reduce airway inflammation which may improve asthma control. this research was done in asthmatic patients who didn't need inhaled steroids to control their asthma. at the moment the investigators are studying to see if there is a benefit of beta-blocker use for asthma over and above asthmatics own usual doses of inhaled steroids. in this study, the investigators will be trying to find out if adding a beta blocker to a smaller dose of steroid inhaler has the same effect on asthma control as just using a higher dose of steroid inhaler by itself.


Eligibility criteria:
inclusion criteria: * stable mild to moderate asthma * histamine pc20 \</= 8mg/ml * receiving inhaled corticosteroid 0-1000ug daily (bdp equivalent dose) * fev1 \> 60% predicted * diurnal variability \< 30% * reliever use \</= 8puffs/day * ecg demonstrating sinus rhythm exclusion criteria: * uncontrolled symptoms of asthma * systolic bp\<110mmhg * heart rate\<60bpm * pregnancy or lactation * heart block * heart rate limiting medications currently prescribed * asthma exacerbation within 6 months of study commencement

Keywords: asthma propranolol inhaled corticosteroids steroid sparing agent airway hyper-responsiveness
an expanded access program for am0010 (pegilodecakin)

Conditions: Melanoma; Prostate Cancer; Ovarian Cancer; Renal Cell Carcinoma; Colorectal Carcinoma; Pancreatic Carcinoma; Non-small Cell Lung Carcinoma; Solid Tumors; Breast Cancer

Summary: this is an expanded access program (eap) available to patients who have advanced cancers, who have failed or progressed on standard of care systemic therapy and do not qualify for ongoing clinical trials.


Eligibility criteria:
* patient is not eligible for other am0010 clinical trials currently open in the region * patient is in urgent need of therapy who fail to meet eligibility criteria for other clinical trials related to am0010 (peg-il-10) can be considered for enrollment into this expanded access program. * patient has advanced cancer in indications where preliminary anti-tumor efficacy of am0010 has been demonstrated or where am0010 mediated immune activation is likely to benefit the patient. * patient has failed or progressed on standard of care (soc) systemic therapy * patient is refusing soc therapy
laas (losartan anti-atherosclerosis study)(0954-330)(completed)

Conditions: Hypertension

Summary: the primary objective of this study is to evaluate efficacy, arterial stiffness measured by pulse wave velocity (pwv) of losartan potassium group compared to carvedilol group after 24 weeks of treatment in patients with the essential hypertension.


Eligibility criteria:
inclusion criteria: * male or female adults, 18 years or over * essential hypertension with mean sbp (systolic blood pressure) ≥ 140 mm hg or mean dbp (diastolic blood pressure) ≥ 90 mm hg\* when blood pressure is measured at visit 1(week -2) and at visit 2(week 0). if diabetes patients, mean sbp ≥ 130 mm hg or mean dbp ≥ 80 mm hg (mean of blood pressure values measured consecutively at least 2 minutes apart) * patient who is willing to, and is able to sign the informed consent form exclusion criteria: * patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study * patient has known or suspected secondary hypertension of any etiology * patient has history of malignant hypertension * patient has history of cerebrovascular accident (cerebral infarction) or myocardiac infarction within the last 6 months * patient takes antihypertensive drugs
pediatric mask fit study

Conditions: Respiratory Tract Infections

Summary: this study will evaluate the performance of various face masks and respirators on children by examining their fitted filtration efficiency (ffe) and mask fit. it will also evaluate the impact of different types of mask modifications (for example, twisting the ear loops, tuck and tie) on ffe and mask fit, with the goal of determining how to optimize mask performance in children. it will also provide information on mask and respirator comfort and acceptability. this data will help inform public health messaging around mask choice for children and also modifications that can be made to improve fit for children who may not have access to various mask types.

this will be a prospective cross-sectional study of 200 children aged 4 to 17 years. participants will be assigned to either the mask type assessment (objective 1) or the mask modification assessment (objective 2) and have a date and time scheduled for testing. the mask type assessment will compare the ffe and fit factor of a cloth mask, child and adult medical mask, child and adult kn95 respirator, and n95 respirator. the mask modification assessment will compare the ffe and fit factor of a child medical mask, adult medical mask with and without modifications (tuck and tie, twisted ear loops), and child and adult n95 respirator. quantitative fit testing will be conducted using a tsi portacount pro respirator fit tester model 8038+. testing will be performed in an identified designated area at the hospital or in the community (i.e., schools or community center), monitored for ventilation, temperature and humidity. we will also measure the ambient particles to ensure adequate particle count. the participants will be asked to evaluate the mask, respirator or modification based on a variety of criteria including comfort, breathability and acceptability. this will be completed immediately after the fit assessment.

Eligibility criteria:
inclusion criteria: * aged 4-17 * able to tolerate wearing a mask exclusion criteria: * children will be excluded if they have contraindications to wearing a mask.
coasting versus antagonist protocol in patients at high risk of ohss

Conditions: Ovarian Hyperstimulation Syndrome

Summary: the aim of this work is to study the value of gnrh antagonist subcutaneous administration as an alternative to coasting in prevention of severe ohss and its impact on embryos quality \& the outcome of icsi.

infertility affects up to one in seven couples all over the world. in vitro fertilization-embryo transfer (ivf-et) and intracytoplasmic sperm injection (icsi) are commonly used in the management of infertility attributable to tubal factor, significant endometriosis, male factor and also persistent unexplained infertility. recruitment and development of multiple follicles in response to gonadotrophin stimulation are necessary for successful assisted reproduction. in young ovulating women undergoing ivf treatment, the standard stimulation protocol can result in either poor response or ovarian hyperstimulation syndrome (ohss). ohss is a serious and potentially life-threatening iatrogenic complication of controlled ovarian hyperstimulation (coh) which may cause serious impact on patient's health. ohss is the most feared complication of ivf-related ovarian stimulation, which in its severe form leads to hospitalization and in the worst case scenario fatal complications. as many as 33% of ivf cycles have been reported to be associated with mild forms of ohss. the incidence of moderate ohss is estimated to be between 3% and 6%, while the severe form may occur in 0.1-3% of all cycles. among high risk women the incidence approaches 20%. development of multiple follicles forms the basis of ohss. exogenous human chorionic gonadotrophin (hcg) administration for the final maturation of oocytes or endogenous production of hcg after pregnancy is the second factor needed for the development of severe ohss. severe ohss is characterized by massive ovarian enlargement, pleural effusion, ascites, oliguria, hemoconcentration, and thromboembolic phenomena. coasting is described as a withholding therapy while continuing with releasing hormone agonist/antagonist administration, until safe levels of estradiol (e2) are attained. gnrh antagonists causes an immediate suppression of e2 levels and therefore could prevent ohss in gnrh antagonist cycles. a comparison between coasting and gnrh antagonist administration in women at high risk of ohss during ovarian stimulation for ivf with gnrh agonist long protocol, in the hope of preventing the drawbacks of prolonged coasting.

Eligibility criteria:
inclusion criteria: * infertile women * age 20-40 * at high risk for ohss exclusion criteria: * refuse to participate
vivio as (aortic stenosis) detection study

Conditions: Aortic Stenosis

Summary: evaluate the sensitivity and specificity of the vivio system when used as an aid in the identification of heart sounds associated with severe aortic stenosis.

prospective, non-randomized, multi-center study of adult subjects referred for echocardiography. total of 200 enrolled subjects at 3 sites. up to 10 roll-in subjects per site. enrolled subjects will undergo: vivio data capture, eko stethoscope capture of heart sounds, standard of care transthoracic echocardiogram (tte). vivio analysis will not be available to non-avicena personnel. recorded sounds from the fda-approved eko stethoscope will be presented to an independent expert physician review panel blinded to vivio and tte results, to compare diagnosis of severe as using eko (auscultation) vs. vivio (algorithms).

Eligibility criteria:
inclusion criteria: 1. adult subjects (21 years of age or older). 2. referred for transthoracic echocardiography by physician/primary care provider/cardiologist. 3. willing and able to participate in all study evaluations and allow access to medical testing and records. 4. signed informed consent or have a legally authorized representative who provides informed consent on behalf of the subject. exclusion criteria: 1. acute coronary syndrome, cardiogenic shock or the need for inotropic/mechanical circulatory support. 2. need for bedside echocardiogram (inpatient). 3. prosthetic device previously implanted at aortic valve position. 4. inability to palpate carotid pulse (e.g. due to severe obesity) 5. history of carotid sinus hypersensitivity (i.e. fainting in response to touching or positioning the neck). 6. history of carotid artery disease or treatment (e.g. unstable carotid plaques that might rupture upon massage or endarterectomy). 7. open skin lesions at target site of electronic stethoscope/vivio device examination.
effectiveness of pediatric resuscitation

Conditions: Cardiac Arrest

Summary: the aim of this study was to compare five cpr feedback devices to standard bls in terms of the quality of single rescuer pediatric resuscitation. therefore, the investigators hypothesis was that there would be no difference between cpr methods in terms of chest compression quality parameters.

cardiac arrest is a leading cause of death worldwide. high-quality chest compressions are of paramount importance for survival and good neurological outcome. unfortunately, even health professionals have difficulty performing effective cpr. chest compression (cc) is often too shallow, compression ratio is inadequate, and hands-off time is too long. cpr feedback devices might be an option for rescuers to in order to increase cc efficiency.

Eligibility criteria:
inclusion criteria: * give voluntary consent to participate in the study * medical profession (paramedics, nurses, physicians) or medical students (nurses, paramedics, physicians) exclusion criteria: * not meet the above criteria * wrist or low back diseases